DZ558A

SEPSIS MARKER
PROCALCITONIN (PCT) ASSAY
Dual Vial Liquid Stable

Diazyme Laboratories introduces the first homogenous PCT assay for use on
virtually all general clinical chemistry analyzers thereby eliminating the need for
high priced dedicated instrumentation. Diazyme’s PCT assay is a cost effective
latex enhanced immunoturbidimetric methodology which utilizes multiple
monoclonal antibodies for enhanced assay sensitivity and specificity. In a recent
multicenter study, the performance of the Diazyme PCT method was found to be
aligned with BRAHMS PCT Kryptor.1

DIAZYME PCT ASSAY ADVANTAGES

• Fast test results (10 minutes) for a rapid turnaround time
• Low sample volume required
• Wide range of instrument parameters available for facilitating and simplifying
implementation
• Liquid stable reagent kit, calibrator and control sets offered separately
• Liquid stable format requires no reagent preparation saving time and reducing
sample handling

REGULATORY STATUS
USA: For Research Use Only

AVAILABLE INSTRUMENT SPECIFIC PACKAGING

• Roche
- Hitachi

INNOVATIONS IN CLINICAL DIAGNOSTICS

PROCALCITONIN (PCT) ASSAY
Dual Vial Liquid Stable

ASSAY SPECIFICATIONS ASSAY PRECISION

Within-run precision of the Diazyme PCT Assay was evaluated. In the study,
Latex Enhanced three levels of PCT controls containing 0.5 ng/mL, 2.14 ng/mL and 13.13 ng/
Method mL PCT respectively were tested with 20 replicates in one run.
Immunoturbidimetric
Level 1 Level 2 Level 3
• Serum
Sample • Plasma Number of Data Points 20 20 20
- EDTA
Type & Mean (ng/mL) 0.50 2.14 13.13
- Li-heparin
Volume
SD (ng/mL) 0.036 0.069 0.353
Sample Volume 20 μL
CV (%) 7.2% 3.2% 2.7%
N = 41
y-intercept = 0.3137 ASSAY INTERFERENCE
Slope = 0.9141
Method The substances normally present in the serum or plasma were tested. Less
R2 = 0.9815 than 10% deviation was produced when tested up to the concentrations shown
Comparison
below:
Samples Ranged From: Ascorbic Acid: 10 mM
0.18 ng/mL - 58.44 ng/mL Bilirubin, free: 40 mg/dL
Bilirubin, conjugated: 40 mg/dL
Hemoglobin: 1000 mg/dL
Linear Range 0.15 – 50 ng/mL Rheumatoid Factor: 100 IU/mL

LOQ 0.15 ng/mL PCT LEVELS AND BACTERIAL INFECTION1

LOD 0.051 ng/mL
CaseCase
of Sepsis
of Sepsis CaseCase
of LRTI
of LRTI
LOQ 0.00 ng/mL PCT PCT Ongoing
Ongoing PCT PCT Bacterial
Bacterial
Infection
(µg/L) (µg/L) Infection Infection
(µg/L) (µg/L) Infection

Calibration 10 10 10 10
6-Point Calibration
Levels

Reagent Very Very

Opened: 2 2 LikelyLikely 2 2
On-Board
Three weeks on board analyzer
Stability 1 1
Very Very
1 1 LikelyLikely
LikelyLikely

0.5 0.5 0.5 0.5

PCT Assay Procedure* Unlikely
Unlikely LikelyLikely
0.25 0.25 0.25 0.25
Very Very
Unlikely
Unlikely Unlikely
Unlikely
0.1 0.1 0.1 0.1

Very Very 1. Li H, et al., Meta-analysis and systematic review

Unlikely
Unlikely of procalcitonin-guided therapy in respiratory tract
infections. Antimicrob Agents Chemother., 2011;
0.01 0.01 0.01 0.01 55:5900-6.
*LRTI - (Lower Respiratory Tract Infection)
present and future. BMC Medicine 2011; 9:107, 1-9.

present and future. BMC Medicine 2011; 9:107, 1-9.

for diagnosis of
infection and guide to antibiotic decisions: past,

Schuetz, P.; et al. Procalcitonin for diagnosis of

infection and guide to antibiotic decisions: past,
888-342-9963 (888-Diazyme)

(888-Diazyme)
Email: sales@diazyme.com

Email: sales@diazyme.com
Website: www.diazyme.com

Website: www.diazyme.com

DIAZYME LABORATORIES
PCT LEVELS &

PCT LEVELS &

BACTERIAL

BACTERIAL

12889 Gregg Court, Poway, CA 92064

INFECTION

INFECTION
P.; et al. Procalcitonin

*Analyzer Dependent PO Box 85608, San Diego, CA 92186

858-455-4768
888-342-9963
858-455-4768

Tel: 858-455-4768 888-DIAZYME

Parameter questions for Procalcitonin (PCT) Assay www.diazyme.com sales@diazyme.com
Schuetz,

should be addressed to Diazyme technical support.

DIAZYME EUROPE GMBH
Please call 858.455.4768 or email
Zum Windkanal 21, 01109 Dresden, Deutschland
support@diazyme.com Tel. +49 (0) 351 886 3300 Fax +49 (0) 351 886 3366
sales@diazyme.de

SHANGHAI DIAZYME CO., LTD.

1. Dipalo, Mariella, Lorena Guido, Gianmatteo Micca, Salvatore
Pittalis, Massimo Locatelli, Andrea Motta, Vincenza Bianchi, Tiziana
Callegari, Rosalia Aloe, Giorgio Da Rin, and Giuseppe Lippi. “Multicenter
Comparison of Automated Procalcitonin Immunoassays.” Practical
Laboratory Medicine 2 (2015): 22-28. Web.
Room 201,1011 Halei Road, Zhangjiang Hi-tech Park
Shanghai, 201203, People’s Republic of China
Tel: 086-21-51320668 Fax: 086-21-51320663
www.lanyuanbio.com service@lanyuanbio.com

DZ062 (06/2016) MK099 Rev. E